Irritability

    Memory decreased

    Paresthesia

    Central nervous

       System stimulation

3%

-

1%

2%

2%

3%

2%

1%

2%

1%

1%

1%

Respiratory

    Pharyngitis

    Sinusitis

    Increased cough

 

3%

3%

1%

 

11%

1%

2%

 

2%

2%

1%

Skin

    Sweating

    Rash

    Pruritus

    Urticaria

 

6%

5%

2%

2%

 

5%

4%

4%

1%

 

2%

1%

2%

0%

Special senses

    Tinnitus

    Taste perversion

    Amblyopia

 

6%

2%

3%

 

6%

4%

2%

 

2%

-

2%

Urogenital

    Urinary frequency

    Urinary urgency

    Vaginal hemorrhage

      Urinary tract infection

 

2%

-

0%

1%

 

5%

2%

2%

0%

 

2%

0%

-

-

 

530    *Adverse events that occurred in at least 1% of patients treated with either 300 or

531    400 mg/day of the sustained-release formulation of bupropion, but equally or more

532    frequently in the placebo group, were: abnormal dreams, accidental injury, acne, appetite

533    increased, back pain, bronchitis, dysmenorrhea, dyspepsia, flatulence, flu syndrome,

534    hypertension, neck pain, respiratory disorder, rhinitis, and tooth disorder.

 

535    Incidence based on the number of female patients.

536    – Hyphen denotes adverse events occurring in greater than 0 but less than 0.5% of patients.

537     

538         Additional events to those listed in Table 4 that occurred at an incidence of at least 1% in

539    controlled clinical trials of the immediate-release formulation of bupropion (300 to 600 mg/day)

540    and that were numerically more frequent than placebo were: cardiac arrhythmias (5% vs 4%),

541    hypertension (4% vs 2%), hypotension (3% vs 2%), tachycardia (11% vs 9%), appetite increase

542    (4% vs 2%), dyspepsia (3% vs 2%), menstrual complaints (5% vs %), akathisia (2% vs 1%),

543    impaired sleep quality (4% vs 2%), sensory disturbance (4% vs 3%), confusion (8% vs 5%)

 

17

 

 

 

 

 

Back a Page
Next Page
Back to Wellbutrin XL NDA Index Page
Back to Main Index Page

Hosted by www.Geocities.ws

1